Open-label clinical phase 1/2 study to assess the safety and efficacy of the SpectraCure P18 System and verteporfin for injection for the treatment of primary localized prostate cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

SpectraCure AB (publ)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-05-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To demonstrate that the use of the SpectraCure P18 System and verteporfin for injection is a safe treatment for patients with organ-confined prostate cancer diagnosed within the last 9 months Patients will be subject to a dose escalation to determine the safe maximum light threshold dose starting at 20 J/cm2.

Secondary objectives 3

1. Device performance: To demonstrate that the SpectraCure P18 System is able to calculate, deliver, and control the required light dose and the positioning of the fibers for the elimination of cancer cells in localized primary prostate cancer tumors.
2. Adequacy of effectiveness: To determine the safe and most effective light dose by MRI response and adverse events.
3. Efficacy: To ascertain the dose level and assess the clinical efficacy of the SpectraCure P18 System and verteporfin for injection for the treatment of primary prostate cancer.

Conditions and MedDRA coding

Primary localised prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. Subjects ≥ 18 years.
2. Histologically confirmed organ-confined prostate cancer diagnosed within the last 9 months. Including subjects on active surveillance with evidence of disease progression and a prostate biopsy not older than 9 months. a. This prostate biopsy should be targeted and systematic (transperineal or transrectal are both acceptable) and include both systematic sampling with a minimum of 8 cores (4 right, 4 left) as well as MRI fusion targeted cores. The minimum number of targeted cores is two (2) but more may be included at the discretion of the surgeon.
3. Gleason Score 7 (3+4 or 4+3).
4. PSA ≤ 15 ng/mL.
5. Lesion volume on mpMRI < 1.5 cm3.
6. Adequate stage imaging such as pelvic CT/MRI/PET scan within the last 6 months confirming localized cancer. • Bone scan is optional if PSA < 10 ng/mL.
7. Treatment target volume <50 cm3 defined by TRUS or MRI.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. Expected survival ≥ 36 months.
10. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
11. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl
12. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
13. Only persons who use an effective method of contraception (condom is recommended) or whose sexual partner is de facto unable to conceive a child for other reasons are included.
14. Signed Informed Consent.

Exclusion criteria 17

1. Evidence of locally advanced, regional pelvic lymph node metastasis, or metastatic disease.
2. Any suspicious for, probable, or definite extracapsular extension on pretreatment MRI
3. Contralateral PIRADS 4/5 lesion (even if negative targeted biopsy)
4. High volume GG1 disease in the contralateral prostate, outside of the ablation zone. High volume is defined as >1 core of GG1 with a linear amount of carcinoma >6mm.
5. Prior radical surgery for carcinoma of the prostate, prior pelvic radiation, prior TURP, prior cryosurgery of the prostate.
6. Prior treatment with any form of brachytherapy.
7. Previous androgen deprivation therapy (ADT) or chemotherapy for prostate cancer.
8. Prior or current bleeding diathesis.
9. Tumors known to be eroding into a major blood vessel in or adjacent to the illumination site.
10. Use of Alpha-reductase inhibitors (ARIs) within 90 days of enrolment.
11. Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).
12. Mental incapacity or psychiatric illness that would interfere with the subject’s ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator.
13. Contraindication for photosensitizer including: a. Porphyria or other diseases exacerbated by light. b. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients. c. Known allergies to porphyrins.
14. On-going therapy with a photosensitizing agent.
15. Enrolment in another therapeutic clinical study within 3 month prior to enrolment and throughout the study.
16. Contraindication for MRI/Gadolinium contrast such as: implants, hip prosthesis, severe renal impairment (glomerular filtration rate [GFR] <30 mL/min/1.73m2), or previous contrast reactions.
17. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Safety: Assessment of toxicity according to CTCAE v5.0 related to therapy per protocol. In addition, any PDT-mediated severe damage to the periprostatic tissues will be evaluated by MRI images obtained 5-9 days post-PDT. The threshold for success is anticipated to be no Grade 3 toxicity to the rectum or bladder assessed on MRI or any drug-related Serious Adverse Events.

Secondary endpoints 3

1. Device performance: Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects.
2. Adequacy of effectiveness: Extent of quantifiable treatment effect in the prostate evaluated by MRI one-week post-PDT by calculating the percentage of necrosis evaluated by MRI. Descriptive statistics will be presented for each subject.
3. Efficacy: Percentage of subjects with negative in-field biopsies (histopathologically tumour free) at 6 months. A proportion of subjects with negative biopsies of 0.75 at 6 months in phase 2 is expected and is considered clinically meaningful. The rate of negative in-field biopsy at 6 and 18 months as defined by the Delphi consensus criterion (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

SpectraCure AB (publ)

Sponsor organisation

SpectraCure AB (publ)

Address

Gasverksgatan 1, St Peters Kloster St Peters Kloster

City

Lund

Postcode

222 29

Country

Sweden

Scientific contact point

Organisation

SpectraCure AB (publ)

Contact name

Head of Clinical Affairs

Public contact point

Organisation

SpectraCure AB (publ)

Contact name

Head of Clinical Affairs

Third parties 4

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications